NCT07508618

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 846 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is: Can Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation? Participants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result. If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. Regardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Qi Dong Yi Xin Granules	If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.
DRUG	Placebo	If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

5 sites across 1 country: China